The Effects of Coenzyme A Combined With Statin on Serum Lipids in Patients With Hyperlipidemia

Zhejiang University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Hyperlipoproteinemia

Treatments: Drug: Coenzyme A; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01928342

2012MMXX2CoA008

Details and patient eligibility

About

The purpose of this study is to evaluate the lipid lowering effects and clinical safety of a natural hypolipidemic compound, coenzyme A （CoA） capsule, combined use with statin, in Chinese patients with moderate dyslipidemia.

Full description

Although lowering cholesterol and low-density lipoprotein-cholesterol (LDL-C) is the mainstay of medical therapy for cardiovascular event prevention, evidence from clinical trials supports a role for elevated triglyceride (TG) and low high-density lipoprotein cholesterol (HDL-C) concentrations in the residual cardiovascular risk on statin treatment. Fenofibrate is the most commonly used agent to control hypertriglyceridemia as monotherapy or combining with statin, which lowers TG and raises HDL-C through multifaceted mechanism by PPARα activation. However, safety of coadministration of statin with fenofibrate has been a great concern, especially drug-induced hepatotoxicity when they are combined used. Coenzyme A (CoA) functions as an acyl group carrier and assists in transferring fatty acids from the cytoplasm to mitochondria. It is also involved in the oxidation and catabolism of fatty acids. Animal studies have proved its lipid-lowering effects. In a previous multicenter study we conducted in 2008, it was found that oral CoA 400U/d effectively lowered serum TG levels in hypertriglyceridemia patients without increasing adverse effects when compared with placebo. So, the present study was performed to further investigate the lipid-lowing effects and safety of CoA capsule combined with statin in dyslipidemia patients.

Enrollment: 320 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• TG 2.3～7.0mmol/l
• 18-80 years of age
• combined use with statins

Exclusion criteria

• pregnancy
• acute liver disease or hepatic dysfunction, as determined by levels of alanine aminotransferase (ALT) or aspartate aminotransferase levels (AST) more than 2-fold the upper normal limit
• nephrotic syndrome or serum creatinine (Cr) ≥2-fold the upper normal limit and creatine phosphokinase (CK) more than 3-fold the upper normal limit
• primary hypothyroidism
• psychiatric patients
• poorly controlled hypertension, as indicated by a Systolic Blood Pressure >180 mmHg or Diastolic Blood Pressure >110 mmHg
• using contraceptive agent
• using immunosuppressive drugs, prohibited medication or other non-statin lipid-lowing drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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320 participants in 2 patient groups, including a placebo group

Coenzyme A 400mg

Experimental group

Description:

Coenzyme A 400mg per day

Treatment:

Drug: Coenzyme A

Placebo

Placebo Comparator group

Description:

Capsule without coenzyme A.

Treatment:

Drug: Placebo